Drugs

Esperion Moving Ahead with Bempedoic Acid Trials

Esperion Therapeutics says it plans to start global pivotal Phase 3 efficacy and safety studies of its bempedoic acid for lowering low density lipoprotein cholesterol (LDL-C) in the fourth quarter of this year, along with a global cardiovascular outcomes trial in patients with elevated LDL-C levels who are unable to tolerate statins.

The company says that in conversations with FDA it reached alignment on the definition of statin intolerance, key design features of the cardiovascular outcomes trial, and the regulatory approval pathway for a cardiovascular disease risk reduction indication in statin intolerant patients. However, it says, FDA did not provide clarity on a regulatory pathway for an LDL-C lowering indication in statin intolerant patients.

“The agency indicated its position regarding an LDL-C lowering indication could be impacted by potential future changes in their view of LDL-C lowering as a surrogate endpoint or the possibility of a shift in the future standard of care for statin intolerant patients with elevated LDL-C levels,” Esperion says. “In the event LDL-C lowering is no longer a surrogate endpoint for initial approval in the future, Esperion would plan to submit a NDA to FDA for a cardiovascular disease risk reduction indication on the basis of a successful completion of the cardiovascular outcomes trial, which would include the results of the LDL-C lowering efficacy studies, by 2022.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome